Training Manager
Roche - San Francisco, CA

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Purpose : · Provide governance in the implementation of the PT Quality Training system and GMP Regulations training. · Lead the development and management of Quality training programs for Global Quality and Compliance and the overall PT organization · Ensure GMP training reflects the requirements of the Pharmaceutical Quality System. · Partner with functional area subject matter experts and leaders to deliver to predefined expectations
        Job Description : · Provide governance on the PT Quality Training system requirements, process · Partner with leadership, PT Learning and functional area subject matter experts to deliver to learning results · Provide QA and Compliance oversight and support for PT Learning team as it relates to CHRIS LSO. · Drive the development and continual improvement of global Quality education/training programs in collaboration with the PT Learning organization. This includes but is not limited to: o Partner with internal groups (External collaborations, inspection management, Audit, etc.) to help identify and analyze training needs o Lead the management of the Global Quality Certification Program (US and Europe). Ensure program content remains current, execute annual application process o Develop, maintain and manage the Global Investigator Certification Program o Define the strategy, develop and deploy GMP Regulations training courses for all PT employees. Ensure current and new GMP and Health Authority regulations are incorporated into training courses. o Develop, maintain and manage a Quality Training Program for Managers · Utilize standard tools and consistent methodology in the development of training programs · Monitor and evaluate training activities and program effectiveness · Independently identify and recommend solutions to procedural, process and system gaps in support of departmental and organizational process improvements · Maintain effective working relationships with local and global stakeholders · Develop and report training related metrics to raise awareness of training compliance · Stay aware of GMP trends and suggest new training to ensure PT is positioned to keep current with GMPs. · BA/BS in Scientific and Technical discipline, with 8-11 years experience in healthcare/biotech/pharmaceutical industry · Ability to understand and interpret cGMP, the relationship with PQS to ensure training materials support continual learning · Extensive knowledge of manufacturing, cGMPs and compliance topics · Knowledge of adult learning theory and learning design · Strong Quality orientation with attention to detail and delivery of service excellence · Must work well in a collaborative team environment and communicate effectively with all levels of the organization, demonstrating excellent written and verbal communication skills · Create and manage work plans and timelines and establishes own priorities and can manage parallel activities simultaneously · Demonstrated influencing and interpersonal skills, and the ability to work well with others in a proactive, positive and constructive manner

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        Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...